| CTRI Number |
CTRI/2024/07/070052 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study in pain management of osteoarthritis by oral intake of Bhanga choorn. |
|
Scientific Title of Study
|
An Open Clinical trial to evaluate the effectiveness of Bhanga Choorn in pain management w.s.r. to Osteoarthritis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Heena Kaushik |
| Designation |
PG scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Room no 86, PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8587936080 |
| Fax |
|
| Email |
heenakaushik17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Heena Kaushik |
| Designation |
PG scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Room no 86, PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8587936080 |
| Fax |
|
| Email |
heenakaushik17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Heena Kaushik |
| Designation |
PG scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Room no 86, PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8587936080 |
| Fax |
|
| Email |
heenakaushik17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra, Haryana-136118, India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
| Address |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Brijendra Singh Tomar |
Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
Room no 86, PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra, Haryana-136118
Kurukshetra
HARYANA |
8950264121
drbs_tomar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna AYUSH University, Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Bhanga Choorn, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: The shoolghna properties of bhanga are mentioned in the rasa tarangni, so its shoolghna karma ( analgesic ) is being evaluated in osteoarthritis. Bhanga patra choorn will be used to evaluate this. |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed patients having complaint of pain due to osteoarthritis.
2.Age between 25 to 50 years irrespective their gender. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from systemic diseases such as uncontrolled hypertension/Diabetes/Cardiac/Cancer/Pulmonary/Renal or hepatic dysfunction.
2.Patients suffering from HIV/VDRL.
3.Pregnant or breast feeding women.
4.Patient with inability comprehend and complete proposed course of intervention. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess relief in pain after intake of Bhanga choorn in osteoarthritis |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the efficacy of Bhanga choorn in pain management of osteoarthritis.
2.To assess the improvement in quality of life of the patients. |
follow up on 35 day after treatment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain is prevalent condition that affects millions of people worldwide and osteoarthritis is a such disease which require pain management during its treatment. Bhanga has been used for for its medicinal value and research has shown promising results in its ability to alleviate pain. Therefore, the clinical effectiveness of bhanga choorn for pain management in patients is important for several reason. Duration of the study will be of 28 days with follow up interval of 14th, 28th, & 35th day with therapeutic dose of 250mg BD under informed consent and the outcome of the study will be assessed using VAS ( visual analogue scale). Conclusion will be drawn after applying appropriate statistical test. |